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Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study

Sponsor
Axio Biosolutions Pvt. Ltd. (Other)
Overall Status
Completed
CT.gov ID
NCT03108365
Collaborator
(none)
40
Enrollment
2
Arms
15.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.

Condition or Disease Intervention/Treatment Phase
  • Device: Axiostat
  • Device: Cotton Gauze
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Actual Study Start Date :
Dec 19, 2014
Actual Primary Completion Date :
Mar 24, 2016
Actual Study Completion Date :
Mar 24, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Axiostat

Size: 1 x 1 cm Chitosan based haemostatic dressing

Device: Axiostat
Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site. Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.
Other Names:
  • Chitosan haemostatic dressing

    		•
    Active Comparator: Cotton Gauze

    Size: 1 x 1 cm

    Device: Cotton Gauze
    Size: 1 x 1 cm

    Outcome Measures

    Primary Outcome Measures

    1. Time to achieve haemostasis [1 Day]

      Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.

    Secondary Outcome Measures

    1. Pain & Healing Scale [Upto 1 Day]

      Patients comfort level as assessed by verbal inquiry after completion of procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion criteria

    • Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)

    • If present, sugar level should be under control

    Exclusion criteria

    • Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Axio Biosolutions Pvt. Ltd.

    Investigators

    • Principal Investigator: Dr. Tejraj Kale, KLE Dental College, Belgaun

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Axio Biosolutions Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT03108365
    Other Study ID Numbers:
    • ABPL/004
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Apr 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hemostatics
    Chitosan

    Study Results

    No Results Posted as of Jul 5, 2019